Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study to Optimize Cytokine Release Syndrome for Glofitamab with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a condition where the body produces abnormal B-cells, a type of white blood cell. The study is specifically for patients whose DLBCL has returned or has not responded to previous treatments. The trial will explore the effects of a new treatment combination that includes the medications Glofitamab, Gemcitabine, and Oxaliplatin. Glofitamab is a type of protein-based medication, while Gemcitabine and Oxaliplatin are chemotherapy drugs that help stop the growth of cancer cells.

The purpose of the study is to understand how this combination of medications affects a condition known as Cytokine Release Syndrome (CRS), which can occur when the immune system reacts strongly to certain treatments. The study will monitor how often CRS happens and how severe it is when patients receive the treatment. Patients will receive the medications through an intravenous (IV) infusion, which means the drugs are given directly into the bloodstream through a vein. The study will also look at how well patients tolerate the treatment and any side effects they might experience.

Participants in the study will receive the treatment over a period of time, with regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on the safety and effectiveness of this treatment combination for patients with relapsed or refractory DLBCL. The trial is expected to continue for several years, allowing researchers to gather comprehensive data on the treatment's impact on patients' health and quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The initial assessment involves confirming eligibility based on specific criteria such as life expectancy of at least 12 weeks and a confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma.

    A comprehensive review of medical history and previous treatments is conducted to ensure suitability for the study.

  2. Step 2

    Treatment initiation

    Treatment begins with the administration of medications through IV infusion. The medications include oxaliplatin, gemcitabine, glofitamab, and obinutuzumab.

    The specific dosages and frequency of administration are determined by the study protocol and are tailored to each participant's needs.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring is conducted to evaluate the response to treatment and to identify any side effects. This includes assessing the incidence of cytokine release syndrome (CRS) and other adverse events.

    The severity of any side effects is graded according to established criteria, and adjustments to the treatment plan may be made as necessary.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are scheduled to track the progress of the disease and the effectiveness of the treatment.

    These assessments include imaging studies to measure the size of any remaining lymphoma lesions and to determine the overall response to the treatment.

  5. Step 5

    Completion of study participation

    Upon completion of the study, a final evaluation is conducted to assess the overall outcomes, including the duration of response and survival rates.

    Participants are provided with a summary of their treatment and any recommendations for future care.

Who can join the trial?

8 criteria

  • Participants must have a life expectancy of at least 12 weeks.
  • Participants must have a confirmed diagnosis of **diffuse large B-cell lymphoma (DLBCL)**, which is a type of cancer that affects certain white blood cells.
  • The disease must have returned or not responded to previous treatments, known as **relapsed/refractory disease**.
  • Participants must have received at least one previous treatment that affects the whole body, known as **systemic therapy**. Local treatments like radiation do not count as systemic therapy.
  • If participants have only had one previous treatment, they must not be suitable for a high-dose chemotherapy followed by a procedure called **autologous stem cell transplant (ASCT)**, which is a treatment that uses the patient's own stem cells.
  • Participants must have at least one lymph node that can be measured in two directions and is larger than 1.5 cm, or one area outside the lymph nodes that can be measured in two directions and is larger than 1 cm, as seen on a **CT scan**, which is a type of detailed imaging test.
  • Participants can be of any gender.
  • The study includes vulnerable populations, which means it may include people who are at greater risk of harm or exploitation.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Glofitamab

    is a medication being studied for its potential to help treat patients with a type of cancer called diffuse large B-cell lymphoma, especially when the cancer has returned or not responded to previous treatments. It is being tested to see how it works in combination with other cancer-fighting drugs.

  • Gemcitabine

    is a chemotherapy drug used to treat various types of cancer. In this study, it is combined with other medications to see if it can help improve outcomes for patients with diffuse large B-cell lymphoma.

  • Oxaliplatin

    is another chemotherapy medication that is often used to treat cancer. It is being used in this study alongside other drugs to determine if it can help manage or reduce the symptoms of diffuse large B-cell lymphoma.

What is already known about the treatment

Glofitamab – Glofitamab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is an investigational medication, meaning it is not yet approved for general medical use but is being evaluated for safety and efficacy. The main therapeutic indication for Glofitamab is DLBCL, a type of non-Hodgkin lymphoma. At the molecular level, Glofitamab works by engaging T-cells to target and destroy cancer cells, specifically by binding to CD20 on B-cells and CD3 on T-cells, facilitating an immune response against the lymphoma cells. It is classified as a bispecific monoclonal antibody, a type of targeted cancer therapy.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease can develop in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. DLBCL is known for its aggressive nature, meaning it can progress quickly if not managed. It is the most common subtype of non-Hodgkin lymphoma and can occur at any age, though it is more prevalent in older adults. The progression of the disease can vary, with some cases responding well to treatment while others may be more challenging to manage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516791-15-00Protocol codeGO45434Estimated enrolment100 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).